PMA P910064S011

Device
Reality Female Condom
Applicant
THE FEMALE HEALTH CO.
PMA number
P910064
Supplement
S011
Decision date
1995-11-16

Current openFDA PMA Record

Device
REALITY FEMALE CONDOM
Applicant
The Female Health Co.
PMA number
P910064
Supplement
S011
Product code
MBU
Generic name
Single-use internal condom
Decision date
1995-11-16
Decision code
APPR
Date received
1995-06-08
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A CHANGE IN THE TYPE OF PACKAGING USED TO SUPPLY THE EXTRA LUBRICANT THAT IS SOLD WITH REALITY

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